U.S. Food & Drug Administration (FDA – Class II., Medical Systems) LIBBE Colon Hydrotherapy Systems also known as: colonics, Colon Irrigation, or high enemas are prescription medical devices and are approved only for colon cleansing, when medically indicated, such as before radiologic or endoscopic examinations. To purchase or use a LIBBE System and cleansing nozzles, a practitioner licensed by the laws of the state or country of the user, must direct the use by providing a prescription. If you do not have a licensed medical practitioner in your area, we will assist you with finding one.